NCT02578277已完成1 期
Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Cmax (maximum observed concentration)
研究概览
简要总结
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent
- •Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
- •Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day
- •BMI = weight (kg)/[height(m)]
- •Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) > 40 mIU/mL) and should not be breast feeding
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
排除标准
- •Any significant acute or chronic medical illness
- •Use of tobacco, excessive alcohol
- •Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- •History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds
研究组 & 干预措施
Single sequence, 3-period DDI (drug-drug interaction)
Experimental
Single sequence
干预措施: CYP and transporter probe substrates (Drug)
Single sequence, 3-period DDI (drug-drug interaction)
Experimental
Single sequence
干预措施: BMS-955176 (Drug)
Single sequence, 3-period DDI (drug-drug interaction)
Experimental
Single sequence
干预措施: BMS-955176 plus CYP and transporter probe substrates (Drug)
结局指标
主要结局
Cmax (maximum observed concentration)
时间窗: Days 1 to 18
AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration
时间窗: Days 1 to 18
AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time
时间窗: Days 1 to 18
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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